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Single-Dose Versus 7-Day-Dose Metronidazole for the Treatment of Trichomoniasis in Women: an Open-Label, Randomised Controlled Trial

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Single-Dose Versus 7-Day-Dose Metronidazole for the Treatment of Trichomoniasis in Women: an Open-Label, Randomised Controlled Trial Articles Single-dose versus 7-day-dose metronidazole for the treatment of trichomoniasis in women: an open-label, randomised controlled trial Patricia Kissinger, Christina A Muzny, Leandro A Mena, Rebecca A Lillis, Jane R Schwebke, Laura Beauchamps, Stephanie N Taylor, Norine Schmidt, Leann Myers, Peter Augostini, William E Secor, Martina Bradic, Jane M Carlton, David H Martin Summary Background Among women, trichomoniasis is the most common non-viral sexually transmitted infection worldwide, Lancet Infect Dis 2018; and is associated with serious reproductive morbidity, poor birth outcomes, and amplified HIV transmission. Single- 18: 1251–59 dose metronidazole is the first-line treatment for trichomoniasis. However, bacterial vaginosis can alter treatment Published Online efficacy in HIV-infected women, and single-dose metronidazole treatment might not always clear infection. We October 5, 2018 http://dx.doi.org/10.1016/ compared single-dose metronidazole with a 7-day dose for the treatment of trichomoniasis among HIV-uninfected, S1473-3099(18)30423-7 non-pregnant women and tested whether efficacy was modified by bacterial vaginosis. See Comment page 1169 Department of Epidemiology Methods In this multicentre, open-label, randomised controlled trial, participants were recruited at three sexual (Prof P Kissinger PhD, health clinics in the USA. We included women positive for Trichomonas vaginalis infection according to clinical Prof D H Martin MD, screening. Participants were randomly assigned (1:1) to receive either a single dose of 2 g of metronidazole (single-dose N Schmidt MPH) and Department of Global group) or 500 mg of metronidazole twice daily for 7 days (7-day-dose group). The randomisation was done by blocks Biostatistics and Data Science of four or six for each site. Patients and investigators were aware of treatment assignment. The primary outcome was (Prof L Myers PhD), Tulane T vaginalis infection by intention to treat, at test-of-cure 4 weeks after completion of treatment. The analysis of the University School of Public primary outcome per nucleic acid amplification test or culture was also stratified by bacterial vaginosis status. This trial Health and Tropical Medicine, Tulane University, is registered with ClinicalTrials.gov, number NCT01018095, and with the US Food and Drug Administration, number New Orleans, LA, USA; Division IND118276, and is closed to accrual. of Infectious Diseases, University of Alabama at Findings Participants were recruited from Oct 6, 2014, to April 26, 2017. Of the 1028 patients assessed for eligibility, Birmingham, Birmingham, AL, USA (C A Muzny MD, 623 women were randomly assigned to treatment groups (311 women in the single-dose group and 312 women in the Prof J R Schwebke MD); Division 7-day-dose group; intention-to-treat population). Although planned enrolment had been 1664 women, the study was of Infectious Diseases stopped early because of funding limitations. Patients in the 7-day-dose group were less likely to be T vaginalis positive (Prof L A Mena MD, at test-of-cure than those in the single-dose group (34 [11%] of 312 vs 58 [19%] of 311, relative risk 0·55, 95% CI L Beauchamps MD) and Department of Population 0·34–0·70; p<0·0001). Bacterial vaginosis status had no significant effect on relative risk (p=0·17). Self-reported Health Science (Prof L A Mena), adherence was 96% in the 7-day-dose group and 99% in the single-dose group. Side-effects were similar by group; the University of Mississippi most common side-effect was nausea (124 [23%]), followed by headache (38 [7%]) and vomiting (19 [4%]). Medical Center, University of Mississippi, Jackson, MS, USA; Section of Infectious Diseases, Interpretation The 7-day-dose metronidazole should be the preferred treatment for trichomoniasis among women. Louisiana State University Health Sciences Center, Funding National Institutes of Health. New Orleans, LA, USA (R A Lillis MD, Prof S N Taylor MD, Prof D H Martin); Division of Copyright © 2018 Elsevier Ltd. All rights reserved. Parasitic Diseases and Malaria, Centers for Disease Control and Introduction and preterm delivery) in women.4 Several studies have Prevention, Atlanta, GA, USA 5 (W E Secor PhD, P Augostini); Among women, trichomoniasis is estimated to be the found that trichomoniasis co-occurs with other STIs and and Center for Genomics and 6 most common non-viral sexually transmitted infection amplifies HIV acquisition. Systems Biology, Department (STI) worldwide, and is as prevalent as chlamydia, Both WHO and the US Centers for Disease Control of Biology, New York gonorrhoea, and syphilis combined.1 Trichomoniasis is and Prevention (CDC) recommend a single 2 g dose of University, New York, NY, USA (Prof J M Carlton PhD, not a reportable disease, but an estimated 143 million oral metronidazole or tinidazole as first-line treatment M Bradic PhD) new cases occur globally each year in women aged and a 7-day dose of oral metronidazole (400 mg or 500 mg Correspondence to: 1 15–29 years. The prevalence of trichomoniasis has been twice daily for 7 days) as second-line treatment for Prof Patricia Kissinger, estimated to be around 5% among women worldwide1 Trichomonas vaginalis infections.7,8 In most settings, Department of Epidemiology, and around 1·8% among women in the USA, but nearly metronidazole is used more often than tinidazole, Tulane University School of five times higher among African American women.2 because purchase costs are lower.9 Public Health and Tropical Medicine, Tulane University, Trichomoniasis has been associated with serious Evidence has shown that the single-dose treatment of New Orleans, LA 70112, USA reproductive morbidity (eg, vaginitis, cervicitis, ure- metronidazole might be insufficient to treat tricho moniasis. [email protected] thritis, and endometritis)3 and poor birth outcomes A meta-analysis10 of six published studies found that women (eg, premature rupture of membranes, low birthweight, who received the 7-day-dose metronidazole had 46% fewer www.thelancet.com/infection Vol 18 November 2018 1251 Articles Research in context Evidence before this study was mostly found among women with co-occurring bacterial Among women, trichomoniasis is the most common non-viral vaginosis. The purpose of this study was to re-evaluate the sexually transmitted infection worldwide. It has been associated efficacy of single-dose metronidazole compared with 7-day-dose with increased reproductive and perinatal morbidity, and metronidazole among HIV-uninfected women, and to amplified HIV acquisition. A single 2 g dose of oral metronidazole examine treatment differences by bacterial vaginosis status. is the recommended first-line treatment of trichomoniasis, with Added value of this study a 7-day dose (400 or 500 mg twice daily for 7 days) as Our findings add to the evidence that 7-day-dose second-line treatment. A meta-analysis of six published studies metronidazole is superior to single-dose metronidazole for found that multiple doses of metronidazole resulted in fewer the treatment of trichomoniasis in women, irrespective of treatment failures than single-dose treatment. However, five of bacterial vaginosis status. the studies were done more than 30 years ago. In our 2010 study with HIV-infected women, we found that women receiving the Implications of all the available evidence 7-day-dose metronidazole treatment were half as likely to be The 7-day dose should be the preferred first-line treatment for Trichomonas vaginalis-positive at test-of-cure compared with T vaginalis infection. Treatment guidelines for trichomoniasis in those receiving the single-dose treatment, but this difference HIV-uninfected women should be refined accordingly. treatment failures than did women who received the single and accommodate for the possibility of lack of adherence dose, and the proportion of patients with positive test-of- and sexual re-exposure among women who received cure (TOC) after single-dose metronidazole ranged from treatment over multiple days. 6·2% to 18%. Five of the six studies concluded that single- Women who attended one STI clinic in each of three US dose treatment was similar to the 7-day treatment.11–15 cities (Birmingham, AL; Jackson, MS; and New Orleans, However, all but one of these studies were done over LA) for clinical screenings and who had a T vaginalis 30 years ago, when clinical trial protocols were not as infection were referred to study staff by their clinical rigorous as today.16 Most of the studies were not adequately providers. powered to detect meaningful differences, and all were Inclusion criteria for participants were female sex, done before the availability of nucleic acid amplification English speaking, reached the age of majority (between tests (NAATs), which are three-to-five times more sensitive 18 and 19 years, depending on site requirements), than microscopy for the diagnosis of trichomoniasis.17–21 The positive for T vaginalis infection according to clinical most recent study that was included in the meta-analysis screening (microscopy or NAAT) confirmed by at least was our 2010 multicentre study of trichomoniasis one study test (NAAT or culture), willingness to refrain treatment.22 We used newer clinical trial methods but only from all alcohol use during treatment and for 24 h after included HIV-infected women with laboratory-diagnosed treatment, willingness to be treated with metronidazole, T vaginalis. We found that women receiving the 7-day-dose and willingness to be randomly assigned to either of the metronidazole treatment
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